US4173626A - Sustained release indomethacin - Google Patents

Sustained release indomethacin Download PDF

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Publication number
US4173626A
US4173626A US05/968,608 US96860878A US4173626A US 4173626 A US4173626 A US 4173626A US 96860878 A US96860878 A US 96860878A US 4173626 A US4173626 A US 4173626A
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United States
Prior art keywords
indomethacin
pellets
weight
coated
capsule
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Expired - Lifetime
Application number
US05/968,608
Inventor
Robert E. Dempski
Gunvant N. Mehta
Joseph C. Saboe
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Merck and Co Inc
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Merck and Co Inc
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Publication date
Application filed by Merck and Co Inc filed Critical Merck and Co Inc
Priority to US05/968,608 priority Critical patent/US4173626A/en
Application granted granted Critical
Publication of US4173626A publication Critical patent/US4173626A/en
Priority to CA000341341A priority patent/CA1149742A/en
Priority to BG96105A priority patent/BG60753B2/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404Indoles, e.g. pindolol
    • A61K31/405Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs

Definitions

  • This invention is concerned with a novel pharmaceutical formulation for the sustained release of indomethacin.
  • the formulation consists of a capsule comprising uncoated pellets of indomethacin, coated pellets of indomethacin and usually pellets of a non-medicated mixture.
  • Indomethacin has been known for years and has been the most successful non-steroidal antiinflammatory agent available for the treatment of inflammatory diseases such as rheumatoid arthritis and osteoarthritis.
  • the use of indomethacin in the traditional pharmaceutical forms such as tablets and capsules has required the ingestion of three or four unit doses per day.
  • Most patients on this therapeutic regimen are elderly and often taking several other tablets or capsules per day for the treatment of other disease states, such as hypertension, depression or the like. Accordingly, it is important for the convenience of the patient and more particularly to ensure compliance by the patient to the particular therapeutic regimen that the number of unit doses per day be kept to a minimum.
  • indomethacin In addition to patient convenience and compliance, it is important, particularly in the treatment of rheumatoid arthritis, to maintain a continuous antiinflammatory serum concentration of indomethacin. This is difficult to accomplish with the traditional pharmaceutical forms of indomethacin which are rapidly absorbed providing high serum concentrations and then slowly metabolized to low serum concentrations three or four times a day.
  • indomethacin which provides a prolonged antiinflammatory serum level of indomethacin by ingestion of only one unit dose every twelve hours.
  • the sustained release capsule formulation contains uncoated pellets of indomethacin, coated pellets of indomethacin and non-medicated pellets.
  • a loading dose of about 35% of the total indomethacin is supplied by uncoated pellets for immediate release and rapid elevation of plasma levels.
  • a sustaining dose of about 65% of the total indomethacin is supplied by pellets coated with a slowly dissolving polymer.
  • Non-medicated pellets are used as a filler for encapsulation with magnesium stearate as the lubricant.
  • the sustained release pharmaceutical formulation of this invention is a capsule containing 25 to 150 mg of indomethacin presented as:
  • the indomethacin constitutes 10 to 35% by weight of the pellets, and is admixed with: a binding agent constituting 20-40% by weight of the pellet, such as a sugar, for example sucrose, lactose, sorbitol, mannitol, invert sugar, dextrose, fructose or the like, especially sucrose; a second binding agent, constituting about 3 to about 15% by weight of the pellet, such as hydroxypropylmethylcellulose, hydroxypropylethylcellulose, methylcellulose, sodium alginate, sodium carboxymethylcellulose, polyvinyl alcohol, polyvinylpyrrolidone, starch paste, gum acacia, gelatin, or the like; a disintegrating agent constituting about 3-15% by weight of the pellet, such as corn starch, guar gum, gum tragacanth, agar, sodium starch glycolate, or the like; and a diluent constituting 20-40% by weight of the pellet, such as a sugar,
  • the coated pellets are coated with a slow dissolving material, such as polyvinylacetate, methacrylic acid esters, ethylcellulose, polyvinyl alcohol, hydroxypropylmethylcellulosephthalate, cellulose acetate, cellulose acetate phthalate, or the like.
  • a slow dissolving material such as polyvinylacetate, methacrylic acid esters, ethylcellulose, polyvinyl alcohol, hydroxypropylmethylcellulosephthalate, cellulose acetate, cellulose acetate phthalate, or the like.
  • the unit dosage of this invention it is convenient but not necessary to include unmedicated pellets to achieve the correct adjusted fill volume for the capsule. It can be any art recognized placebo mixture but for ease of encapsulation it is desirable to have the placebo in a particle size comparable with the coated and uncoated pellets previously described.
  • the non-medicated portion is not a critical part of the novel unit dose pharmaceutical formulation of this invention. A typical non-medicated pellet is described in the Examples that follow.
  • a lubricant such as talc, stearic acid or magnesium stearate, comprising from about 0.1 to about 1.0% by weight of the capsule contents.
  • the ingredients, previously described are blended, milled and remixed according to acceptable pharmaceutical manufacturing practices.
  • the powder mixture is then granulated with purified water and extruded as rods approximately 1 mm in diameter.
  • the granulated rods placed in a pelletizer, or spheronizer and the resulting pellets are dried.
  • the dried pellets are sized using standard sieves, retaining these pellets between about 500 microns and 1500 microns in size.
  • a preferred size range is about 1190 microns (#16 screen) to about 590 microns (#30 screen).
  • Uncoated indomethacin pellets are coated with a slow dissolving coating agent in accordance with accepted pharmaceutical manufacturing procedures, and dried.
  • the dried pellets are sized as described for the uncoated pellets.
  • the ingredients previously described less the indomethacin are blended, milled and remixed, granulated with purified water and extruded into rods of about 1 mm diameter.
  • the rods are placed in a spheronizer or pelletizer and the resulting pellets are dried.
  • the dried pellets are sized as previously described and retained in an air tight container.
  • These pellets may also contain a pharmaceutically acceptable coloring agent such as FD & C Blue No. 2, FD & C Red No. 3, or the like.
  • the required quantities of uncoated indomethacin pellets and coated indomethacin pellets are selected to achieve the desired content of indomethacin, and to obtain the desired release pattern for the finished product.
  • Non-medicated pellets are added as required to achieve the correct adjusted fill volume for the capsule.
  • These materials are blended with a lubricating agent such as magnesium stearate and encapsulated.

Abstract

A sustained release indomethacin pharmaceutical product is provided that utilizes a pellet formulation encapsulated in a hard gelatin capsule. A portion of the pellets is uncoated for immediate and rapid release of indomethacin for elevating the plasma level. The remainder of the pellets are coated with a polymer to sustain the plasma level. The uncoated and coated pellets may be mixed with non-medicated pellets as a capsule filler.

Description

BACKGROUND OF THE INVENTION
This invention is concerned with a novel pharmaceutical formulation for the sustained release of indomethacin.
The formulation consists of a capsule comprising uncoated pellets of indomethacin, coated pellets of indomethacin and usually pellets of a non-medicated mixture. By this means there is provided immediately available indomethacin for elevating the plasma level and more slowly released indomethacin for sustaining the plasma level at therapeutic doses over prolonged periods of time.
Indomethacin has been known for years and has been the most successful non-steroidal antiinflammatory agent available for the treatment of inflammatory diseases such as rheumatoid arthritis and osteoarthritis. The use of indomethacin in the traditional pharmaceutical forms such as tablets and capsules has required the ingestion of three or four unit doses per day. Most patients on this therapeutic regimen are elderly and often taking several other tablets or capsules per day for the treatment of other disease states, such as hypertension, depression or the like. Accordingly, it is important for the convenience of the patient and more particularly to ensure compliance by the patient to the particular therapeutic regimen that the number of unit doses per day be kept to a minimum.
In addition to patient convenience and compliance, it is important, particularly in the treatment of rheumatoid arthritis, to maintain a continuous antiinflammatory serum concentration of indomethacin. This is difficult to accomplish with the traditional pharmaceutical forms of indomethacin which are rapidly absorbed providing high serum concentrations and then slowly metabolized to low serum concentrations three or four times a day.
With the present invention there is provided a sustained release form of indomethacin which provides a prolonged antiinflammatory serum level of indomethacin by ingestion of only one unit dose every twelve hours.
SUMMARY OF THE INVENTION
In accordance with the present invention, the sustained release capsule formulation contains uncoated pellets of indomethacin, coated pellets of indomethacin and non-medicated pellets. A loading dose of about 35% of the total indomethacin is supplied by uncoated pellets for immediate release and rapid elevation of plasma levels. A sustaining dose of about 65% of the total indomethacin is supplied by pellets coated with a slowly dissolving polymer. Non-medicated pellets are used as a filler for encapsulation with magnesium stearate as the lubricant.
DETAILED DESCRIPTION OF THE INVENTION
The sustained release pharmaceutical formulation of this invention, as a unit dose, is a capsule containing 25 to 150 mg of indomethacin presented as:
(a) Uncoated pellets comprising pharmaceutical carriers and 5-50 mg of indomethacin;
(b) Coated pellets comprising pharmaceutical carriers and 15-145 mg of indomethacin, wherein the coating is a slow dissolving material.
In the coated and uncoated pellets of indomethacin, the indomethacin constitutes 10 to 35% by weight of the pellets, and is admixed with: a binding agent constituting 20-40% by weight of the pellet, such as a sugar, for example sucrose, lactose, sorbitol, mannitol, invert sugar, dextrose, fructose or the like, especially sucrose; a second binding agent, constituting about 3 to about 15% by weight of the pellet, such as hydroxypropylmethylcellulose, hydroxypropylethylcellulose, methylcellulose, sodium alginate, sodium carboxymethylcellulose, polyvinyl alcohol, polyvinylpyrrolidone, starch paste, gum acacia, gelatin, or the like; a disintegrating agent constituting about 3-15% by weight of the pellet, such as corn starch, guar gum, gum tragacanth, agar, sodium starch glycolate, or the like; and a diluent constituting about 10-30% by weight of the pellet, such as microcrystalline cellulose, alginic acid, lactose, maltose, dextrose or the like.
The coated pellets are coated with a slow dissolving material, such as polyvinylacetate, methacrylic acid esters, ethylcellulose, polyvinyl alcohol, hydroxypropylmethylcellulosephthalate, cellulose acetate, cellulose acetate phthalate, or the like.
In the unit dosage of this invention it is convenient but not necessary to include unmedicated pellets to achieve the correct adjusted fill volume for the capsule. It can be any art recognized placebo mixture but for ease of encapsulation it is desirable to have the placebo in a particle size comparable with the coated and uncoated pellets previously described. The non-medicated portion is not a critical part of the novel unit dose pharmaceutical formulation of this invention. A typical non-medicated pellet is described in the Examples that follow.
For ease of encapsulation it is preferred to incorporate a lubricant such as talc, stearic acid or magnesium stearate, comprising from about 0.1 to about 1.0% by weight of the capsule contents.
(A) Uncoated Indomethacin Pellets
The ingredients, previously described are blended, milled and remixed according to acceptable pharmaceutical manufacturing practices. The powder mixture is then granulated with purified water and extruded as rods approximately 1 mm in diameter. The granulated rods placed in a pelletizer, or spheronizer and the resulting pellets are dried. The dried pellets are sized using standard sieves, retaining these pellets between about 500 microns and 1500 microns in size. A preferred size range is about 1190 microns (#16 screen) to about 590 microns (#30 screen).
(B) Coated Indomethacin Pellets
Uncoated indomethacin pellets are coated with a slow dissolving coating agent in accordance with accepted pharmaceutical manufacturing procedures, and dried. The dried pellets are sized as described for the uncoated pellets.
(C) Non-medicated Pellets
The ingredients previously described less the indomethacin are blended, milled and remixed, granulated with purified water and extruded into rods of about 1 mm diameter. The rods are placed in a spheronizer or pelletizer and the resulting pellets are dried. The dried pellets are sized as previously described and retained in an air tight container. These pellets may also contain a pharmaceutically acceptable coloring agent such as FD & C Blue No. 2, FD & C Red No. 3, or the like.
The required quantities of uncoated indomethacin pellets and coated indomethacin pellets are selected to achieve the desired content of indomethacin, and to obtain the desired release pattern for the finished product. Non-medicated pellets are added as required to achieve the correct adjusted fill volume for the capsule. These materials are blended with a lubricating agent such as magnesium stearate and encapsulated.
Examples of typical capsules are shown in Tables I-IV.
              TABLE I                                                     
______________________________________                                    
INDOMETHACIN SUSTAINED RELEASE                                            
CAPSULE COMPOSITION, 75 MG.                                               
Per Capsule Capsule                                                       
(mg)        Composition       Percentage                                  
______________________________________                                    
80          Indomethacin Uncoated                                         
            Pellets                                                       
That contains:                                                            
25          Indomethacin      31.25                                       
28          Confectioner's Sugar                                          
                              35.00                                       
5           Hydroxypropylmethyl-                                          
            cellulose         6.25                                        
7           Starch, Corn USP  8.75                                        
15          Microcrystalline                                              
            Cellulose NF      18.75                                       
______________________________________                                    
165         Indomethacin Coated                                           
            Pellets                                                       
That Contains:                                                            
50          Indomethacin      30.30                                       
56          Confectioner's Sugar                                          
                              33.94                                       
10          Hydroxypropylmethyl-                                          
            cellulose         6.06                                        
14          Starch, Corn USP  8.48                                        
30          Microcrystalline Cellulose                                    
            NF                18.18                                       
5           Polyvinylacetate  3.04                                        
______________________________________                                    
50          White Placebo Pellets                                         
That Contains:                                                            
25          Confectioner's Sugar                                          
                              50.00                                       
5           Hydroxypropylmethyl-                                          
            cellulose         10.00                                       
6           Starch, Corn USP  12.00                                       
14          Microcrystalline Cellulose                                    
            NF                28.00                                       
______________________________________                                    
0.5         Magnesium Stearate USP                                        
295.5       TOTAL NET WEIGHT                                              
______________________________________                                    
              TABLE II                                                    
______________________________________                                    
INDOMETHACIN SUSTAINED RELEASE                                            
CAPSULE COMPOSITION, 25 MG.                                               
Detailed Composition                                                      
Ingredient              mg/Capsule                                        
______________________________________                                    
Uncoated Indomethacin Pellets                                             
                        60.00                                             
which contain:                                                            
Indomethacin            13.9%                                             
Sugar, Powdered with 3% Starch                                            
                        43.9                                              
Hydroxypropylmethylcellulose                                              
                        8.3                                               
NF 50 cps 60 HG                                                           
Microcrystalline Cellulose NF                                             
                        23.3 -Water, Purified USP --                      
Starch, USP, Corn       10.6                                              
______________________________________                                    
Coated Indomethacin Pellets                                               
                        55.00                                             
which contain:                                                            
Indomethacin,           30.3%                                             
Sugar, Powdered with 3% Starch                                            
                        33.9                                              
Hydroxypropylmethylcellulose                                              
                        6.1                                               
NF 50 cps 60 HG                                                           
Starch, USP, Corn       8.5                                               
Microcrystalline Cellulose NF                                             
                        18.2                                              
Cellulose Acetate       5.0                                               
Water, Purified USP     --                                                
SD3A Alcohol, 95%       --                                                
______________________________________                                    
White Non-Medicated Pellets                                               
                        69.75                                             
which contain:                                                            
Sugar, Powdered with 3% Starch                                            
                        51.0%                                             
Hydroxypropylmethylcellulose                                              
                        10.0                                              
NF 50 cps 60 HG                                                           
Starch, USP, Corn       12.0                                              
Microcrystalline Cellulose NF                                             
                        27.0                                              
Water, Purified USP     --                                                
______________________________________                                    
Magnesium Stearate USP  0.25                                              
TOTAL CAPSULE NET WEIGHT                                                  
                        185.0                                             
______________________________________                                    
              TABLE III                                                   
______________________________________                                    
INDOMETHACIN SUSTAINED RELEASE                                            
CAPSULE COMPOSITION, 150 MG.                                              
Detailed Composition                                                      
Ingredient              mg/Capsule                                        
______________________________________                                    
Uncoated Indomethacin Pellets                                             
                        110.0                                             
which contain:                                                            
Indomethacin            31.25%                                            
Sugar, Powdered with 3% Starch                                            
                        35.0                                              
Hydroxypropylmethylcellulose                                              
                        6.25                                              
NF 50 cps 60 HG                                                           
Starch, USP, Corn       8.75                                              
Microcrystalline Cellulose NF                                             
                        18.75                                             
Water, Purified USP     --                                                
______________________________________                                    
Coated Indomethacin Pellets                                               
                        330.0                                             
which contain:                                                            
Indomethacin            30.3%                                             
Sugar, Powdered with 3% Starch                                            
                        34.0                                              
Hydroxypropylmethylcellulose                                              
                        6.1                                               
NF 50 cps 60 HG                                                           
Starch, USP, Corn       8.5                                               
Microcrystalline Cellulose NF                                             
                        16.1                                              
Polyvinylacetate        5%                                                
Water, Purified USP     --                                                
SD3A Alcohol, 95%       --                                                
______________________________________                                    
Non-Medicated Pellets   99.0                                              
which contain:                                                            
Sugar, Powdered with 3% Starch                                            
                        51.0%                                             
Hydroxypropylmethylcellulose                                              
                        10.0                                              
NF 50 cps 60 HG                                                           
Starch, USP, Corn       12.0                                              
Microcrystalline Cellulose NF                                             
                        27.0                                              
FD & C Blue #2, 92% Pure Dye                                              
                        0.05                                              
Water, Purified USP     --                                                
______________________________________                                    
Magnesium Stearate USP  1.0                                               
TOTAL CAPSULE NET WEIGHT                                                  
                        590.0                                             
______________________________________                                    
              TABLE IV                                                    
______________________________________                                    
INDOMETHACIN RELEASE                                                      
CAPSULE COMPOSITION, 75 MG.                                               
Detailed Composition                                                      
Ingredient           mg/Capsule                                           
______________________________________                                    
Uncoated Indomethacin Pellets                                             
                     80.0                                                 
which contain:                                                            
Indomethacin         31.25%    31.25%                                     
Sugar, Powdered with 3% Starch                                            
                     28.00     38.00                                      
Hydroxypropylmethylcellulose                                              
                     8.00      4.25                                       
NF 50 cps 60 HG                                                           
Starch, USP Corn     7.00      10.75                                      
Microcrystalline Cellulose NF                                             
                     25.75     15.75                                      
Water, Purified USP  --        --                                         
______________________________________                                    
Coated Indomethacin Pellets                                               
                     165.0                                                
which contain:                                                            
Indomethacin         30.3%     30.3%                                      
Sugar, Powdered with 3% Starch                                            
                     27.0      25.0                                       
Hydroxypropylmethylcellulose                                              
                     10.0      10.0                                       
NF 50 cps 60 HG                                                           
Starch, USP Corn     5         7.5                                        
Microcrystalline Cellulose NF                                             
                     21.7      22.2                                       
Polyvinylacetate     6%        --                                         
Water, Purified USP  --        --                                         
SD3A Alcohol, 95%    --        --                                         
Ethyl Cellulose      --        5%                                         
______________________________________                                    
Non-Medicated Pellets                                                     
                     49.5                                                 
which contain:                                                            
Sugar, Powdered with 3% Starch                                            
                     45%       54%                                        
Hydroxypropylmethylcellulose                                              
                     8         9%                                         
NF 50 cps 60 HG                                                           
Starch USP Corn      14        11%                                        
Microcrystalline Cellulose NF                                             
                     33%       26%                                        
FD & C Blue #2, 92% Pure Dye                                              
                     0.15%     0.3%                                       
Water, Purified USP  --        --                                         
______________________________________                                    
Magnesium Stearate USP                                                    
                     0.5                                                  
TOTAL CAPSULE NET WEIGHT                                                  
                     295.0 mg                                             
______________________________________                                    

Claims (3)

What is claimed is:
1. A sustained release pharmaceutical formulation in capsule unit dosage form that provides prolonged plasma levels of indomethacin and is clinically effective, containing 25 to 150 mg of 500 to 1500 micron size pellets of indomethacin, in the form of:
(A) Uncoated pellets comprising pharmaceutical carriers and 5-50 mg of indomethacin for immediate release of about 35% of the total indomethacin, and rapid elevation of plasma levels; and
(B) Coated pellets comprising pharmaceutical carriers and 15-145 mg of indomethacin as a sustaining dose of about 65% of the total indomethacin wherein the coating consists of polyvinyl acetate as a slow dissolving material.
2. The pharmaceutical formulation of claim 1, wherein the unit dosage form also includes non-medicated pellets to achieve the correct adjusted fill volume for the capsule.
3. The pharmaceutical formulation of claim 1, wherein component (A) is pellets comprising 10-35% by weight indomethacin; 20-40% by weight confectioner's sugar; 3-15% by weight of hydroxypropylmethylcellulose; 3-15% by weight corn starch; and 15-25% by weight microcrystalline cellulose; and component (B) is component (A) pellets coated with said slow dissolving material.
US05/968,608 1978-12-11 1978-12-11 Sustained release indomethacin Expired - Lifetime US4173626A (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US05/968,608 US4173626A (en) 1978-12-11 1978-12-11 Sustained release indomethacin
CA000341341A CA1149742A (en) 1978-12-11 1979-12-06 Sustained release indomethacin
BG96105A BG60753B2 (en) 1978-12-11 1992-03-19 Indomethacin with depot emission

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US05/968,608 US4173626A (en) 1978-12-11 1978-12-11 Sustained release indomethacin

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BG (1) BG60753B2 (en)
CA (1) CA1149742A (en)

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US4415547A (en) * 1982-06-14 1983-11-15 Sterling Drug Inc. Sustained-release pharmaceutical tablet and process for preparation thereof
WO1984000004A1 (en) * 1982-06-14 1984-01-05 Key Pharma Sustained release aspirin
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US4874614A (en) * 1985-03-25 1989-10-17 Abbott Laboratories Pharmaceutical tableting method
US4904476A (en) * 1986-03-04 1990-02-27 American Home Products Corporation Formulations providing three distinct releases
US4938968A (en) * 1988-07-26 1990-07-03 Norjec Development Associates, Inc. Controlled release indomethacin
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